Patients with an infected femoral non-union
Conditions
Interventions
Group 1: Non-interventional, prospective explorative consecutive cohort study in the form of an investigator initiated trial.
Start date 1.2.2023, Observational time-frame 24 months at least, long ter
Sponsors
BG Klinikum Hamburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Patients that have been treated in the last 2 weeks with a bone implant that is indicated for femoral shaft/distal femoral fracture or fracture non-union in adult humans. Included will be cases that have an antiinfective coating aimed at reducing re-infection rates or received a standard bone implant that is indicated for femoral shaft/femoral fracture or fracture non-union in adult humans. • Written informed consent by patient • Inclusion only if the surgery was performed in accordance with the IFU of the osteosynthesis systems that have been used.
Exclusion criteria
Exclusion criteria: • Contraindications as stated in the manufacturer’s instructions for use (IFU) • Pregnancy • Patient age < 18 years • Patient not able to understand nature of the study or not able to participate in the follow-up examinations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aim of this clinical study is to investigate the healing process and the functional outcome after an osteosynthesis with anti-infective coated or traditionally bone implants as a treatment of bone infection with a relevant bone defect area. This will be valuable information for our internal quality control. The results gained during this study will be used for the planning of a controlled study. | — |
Countries
Germany
Contacts
Public ContactArndt-Peter Schulz
BG Klinikum Hamburg
Outcome results
None listed